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Genomes and Genes | human experimentationSummarySummary: The use of humans as investigational subjects. Top Publications
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Publications
Safety and clinical outcome of experimental challenge of human volunteers with Plasmodium falciparum-infected mosquitoes: an updateJudith E Epstein
Malaria Program, Naval Medical Research Center, Silver Spring, MD, 20910, USA
J Infect Dis 196:145-54. 2007..In 1997, an analysis of experience with 118 volunteers indicated that mosquito inoculation of P. falciparum could be a safe, well-tolerated, reproducible, and efficient method of challenge...
Human experimentation with Neisseria gonorrhoeae: progress and goalsM S Cohen
Department of Medicine, University of North Carolina at Chapel Hill 27599 7030, USA
J Infect Dis 179:S375-9. 1999..The experimental model has proven to be an efficient means of studying gonococcal infection and focusing vaccine development. In addition, this model should allow vaccines to be tested quickly and efficiently...
Justice and the human development approach to international researchAlex John London
Carnegie Mellon University, USA
Hastings Cent Rep 35:24-37. 2005
Experimental malaria in human volunteers: ethical aspectsH K A Visser
Neth J Med 63:41-2. 2005
International Genetic Epidemiology Society: commentary on Darkness in El Dorado by Patrick TierneyM P Baur
Department of Medical Biometry, Informatics and Epidemiology, University of Bonn, Bonn, Germany
Genet Epidemiol 21:81-104. 2001..Ethical issues about scientific research in primitive populations deserve serious and wide discussion, but the IGES condemns the gross misrepresentation of the facts and demonization of the principal characters in this book...
Response to allegations against James V. Neel in Darkness in El Dorado, by Patrick TierneyJames V Neel
Am J Hum Genet 70:1-10. 2002
Reasons for declining to enroll in a phase I and II HIV vaccine trial after randomization among eligible volunteers in Dar es Salaam, TanzaniaEdith A M Tarimo
Division of Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden
PLoS ONE 6:e14619. 2011..The reasons for such a decision are not well known. This article describes why individuals who were randomized in a phase I and II HIV vaccine trial in Dar es Salaam, Tanzania declined to be enrolled...
The age of neuroelectronicsAdam Keiper
The New Atlantis, USA
New Atlantis 11:4-41. 2006
Ethics review for sale? Conflict of interest and commercial research review boardsT Lemmens
Faculty of Law, University of Toronto, 78 Queen s Park, Toronto, Ontario, Canada M5S 2C5
Milbank Q 78:547-84, iii-iv. 2000..The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process...
Research without consent: current status, 2003Michelle H Biros
Department of Emergency Medicine, Hennepin County Medical Center and the University of Minnesota School of Medicine, 701 Park Avenue South, Minneapolis, MN 55415, USA
Ann Emerg Med 42:550-64. 2003....
Exposures recorded for participants in the UK Chemical Warfare Agent Human Research Programme, 1941-1989T J Keegan
Department of Public Health, University of Oxford, OX3 7LF, UK
Ann Occup Hyg 53:83-97. 2009..The study is part of a programme of epidemiological research initiated in response to service veterans' concerns about possible long-term health effects of their participation...
Reconstructing exposures from the UK chemical warfare agent human research programmeTj Keegan
Department of Public Health, University of Oxford, Oxford OX7 3LF, UK
Ann Occup Hyg 51:441-50. 2007..The resulting cohort study has the potential to provide information which will assist in understanding the long-term health impact of chemical warfare agent exposure on these veterans...
Human hallucinogen research: guidelines for safetyMw Johnson
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, Baltimore, MD, USA
J Psychopharmacol 22:603-20. 2008..Incautious research may jeopardize participant safety and future research. However, carefully conducted research may inform the treatment of psychiatric disorders, and may lead to advances in basic science...
Identification of Haemophilus ducreyi genes expressed during human infectionMargaret E Bauer
Department of Microbiology and Immunology, Indiana University School of Medicine, Indianapolis, IN 46202, USA
Microbiology 154:1152-60. 2008..We identified three genes, lspA1, lspA2 and tadA, known to be required for virulence in humans. This is the first study to broadly define transcripts expressed by H. ducreyi in humans...
Therapeutic misconception in clinical research: frequency and risk factorsPaul S Appelbaum
Department of Psychiatry, University of Massachusetts Medical School, USA
IRB 26:1-8. 2004
Assessing benefits in clinical research: why diversity in benefit assessment can be riskyLarry R Churchill
Vanderbilt University, USA
IRB 25:1-8. 2003
Is the concept of informed consent applicable to clinical research involving critically ill patients?John M Luce
San Francisco General Hospital, CA, USA
Crit Care Med 31:S153-60. 2003..Stronger research oversight may be as important as informed consent in protecting patient welfare...
Challenges of ethical research in resource-poor settingsB M Dickens
Faculty of Law, University of Toronto, Toronto, Ontario, Canada
Int J Gynaecol Obstet 80:79-86. 2003..The structure and functions of research ethics review committees present difficult challenges, but they may be mitigated by enlightened international collaboration...
Research ethics and law of healthcare system quality improvement: the conflict of cost containment and qualityW Andrew Kofke
Department of Anesthesia, University of Pennsylvania, Philadelphia 19104 4283, USA
Crit Care Med 31:S143-52. 2003..The ethical and legal foundations exist to support the systematic practice of informing patients of their participation in some types of QI procedures...
Ethical review of health research: a perspective from developing country researchersA A Hyder
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
J Med Ethics 30:68-72. 2004....
Pesticide testing in humans: ethics and public policyChristopher Oleskey
Center for Children s Health and the Environment, Box 1043, Mount Sinai School of Medicine, One Gustav L Levy Place, New York, NY 10029, USA
Environ Health Perspect 112:914-9. 2004..Participants also strongly encouraged active biomonitoring of every pesticide currently in use to track human exposure, particularly in vulnerable populations, and to assess adverse effects on health...
Beyond informed consentZulfiqar A Bhutta
Aga Khan University, Karachi 74800, Pakistan
Bull World Health Organ 82:771-7. 2004..Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings...
Clinical outcome of experimental human malaria induced by Plasmodium falciparum-infected mosquitoesD F Verhage
Departments of' Medical Microbiology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
Neth J Med 63:52-8. 2005..CONCLUSION: With stringent inclusion criteria, close monitoring and immediate administration of treatment upon detection of parasitaemia, experimental human malaria challenges can be considered safe and generally well tolerated...
Recommendations for informed consent forms for critical care clinical trialsHenry J Silverman
University of Maryland School of Medicine, Baltimore, MD, USA
Crit Care Med 33:867-82. 2005..Prospective evaluation is needed to determine whether our recommendations enhance the informed consent process...
Human testing of pesticides: ethical and scientific considerationsAlan H Lockwood
Center for PET 115P, VA Western NY Healthcare System, 3495 Bailey Ave, Buffalo, NY 14215, USA
Am J Public Health 94:1908-16. 2004..An EPA committee that is free from political and financial conflicts of interest should review this practice...
Moving beyond compliance: measuring ethical quality to enhance the oversight of human subjects researchHolly A Taylor
Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
IRB 29:9-14. 2007
Immunotherapy: bewitched, bothered, and bewildered no moreRalph M Steinman
Laboratory of Cellular Physiology and Immunology, Rockefeller University, New York, NY 10021 6399, USA
Science 305:197-200. 2004..We suggest steps to be taken to reinvigorate basic research in human subjects as part of the mainstream of science...
Human subjects issues and IRB review in practice-based researchLeslie E Wolf
University of California, San Francisco, San Francisco, California 94143 0903, USA
Ann Fam Med 3:S30-7. 2005..This article explores the challenges that practice-based research networks (PBRNs) face with respect to the regulatory requirements for institutional review board (IRB) review and the protection of human subjects in research...
Ethics of innovative surgery: US surgeons' definitions, knowledge, and attitudesAngelique M Reitsma
Center for Biomedical Ethics, University of Virginia, PO Box 800758, Charlottesville, VA 22908-0758, USA
J Am Coll Surg 200:103-10. 2005..Some forms of innovation clearly fall under the current regulations for human subject research; others might not fully meet the definition but could still require some additional oversight...
Rationalizing risk assessment in human subject researchCarl H Coleman
Health Law and Policy Program, Seton Hall Law School, USA
Ariz Law Rev 46:1-51. 2004
The role of institutional review boards in protecting human subjects: are we really ready to fix a broken system?Hazel Glenn Beh
William S Richardson School of Law, University of Hawaii, USA
Law Psychol Rev 26:1-47. 2002
Bench-to-bedside review: human subjects research--are more standards needed?David T Huang
CRISMA Laboratory, Department of Critical Care Medicine, Department of Emergency Medicine, University of Pittsburgh, 641 Scaife Hall, Pittsburgh, PA 15261, USA
Crit Care 10:244. 2006..We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine...
Establishing risk of human experimentation with drugs: lessons from TGN1412M J H Kenter
Central Committee on Research Involving Human Subjects, The Hague, Netherlands
Lancet 368:1387-91. 2006
Are the rules for research with subjects with dementia changing?: views from the fieldCarol B Stocking
Section of Geriatrics, MacLean Center for Clinical Medical Ethics, Department of Medicine, University of Chicago, IL 60637, USA
Neurology 61:1649-51. 2003..The real tradeoff between protection and difficulty in conducting research on devastating illnesses needs to be confronted when new regulations in this area are debated...
Human experimentation: a rule gone awry?Adrian Burton
Environ Health Perspect 114:A360-2. 2006
Research on the socio-ethical impact of biomarker use and the communication processes in ECNIS NoE and NewGeneris IPBirgit Dumez
Center for Human Genetics, Department of Medicine, University of Leuven, Herestraat 49, 3000 Leuven, Belgium
Int J Hyg Environ Health 210:263-5. 2007..A harmonized socio-ethical and legal approach not only increases the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of each citizen of the European Union...
Evaluating the quality of informed consentJeremy Sugarman
Phoebe R Berman Bioethics Institute, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA
Clin Trials 2:34-41. 2005..Having such means will be important to monitoring consent and testing potential improvements in the consent process...
Is the argument from marginal cases obtuse?Daniel A Dombrowski
Seattle University, Seattle, WA 98122, USA
J Appl Philos 23:223-32. 2006..The purpose of the present article is to argue that, despite Anderson's and Diamond's nuanced and perceptive treatments of the argument from marginal cases, this argument is not obtuse in either sense of the term...
Vulnerability to influence: a two-way streetGail E Henderson
University of North Carolina School of Medicine, USA
Am J Bioeth 4:50-2; discussion W32. 2004
The therapeutic misconception: problems and solutionsCharles W Lidz
Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts, USA
Med Care 40:V55-63. 2002..The therapeutic misconception is a serious problem for informed consent in clinical research...
The dysregulation of human subjects researchNorman Fost
JAMA 298:2196-8. 2007
Assessment of medical school institutional review board policies regarding compensation of subjects for research-related injuryMichael K Paasche-Orlow
Department of Medicine, Boston University School of Medicine, Boston, Massachusetts 02118, USA
Am J Med 118:175-80. 2005..We hypothesized that informed consent language at U.S. medical schools would be particularly complex and fall short of IOM goals, especially for projects without industry sponsorship...
Regional ethics organizations for protection of human research participantsAnne Wood
School of Law, University of California, Berkeley, Berkeley, California 94720-7200, USA
Nat Med 10:1283-8. 2004
What is a "minor" increase over minimal risk?David Wendler
Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bethesda, MD 20892, USA
J Pediatr 147:575-8. 2005
Principles of early stopping of randomized trials for efficacy: a critique of equipoise and an alternative nonexploitation ethical frameworkDavid Buchanan
Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
Kennedy Inst Ethics J 15:161-78. 2005....
Oversight of human participants research: identifying problems to evaluate reform proposalsEzekiel J Emanuel
Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland 20892 1156, USA
Ann Intern Med 141:282-91. 2004....
Should society allow research ethics boards to be run as for-profit enterprises?Ezekiel J Emanuel
Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, United States
PLoS Med 3:e309. 2006..Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval...
The old faith and the new science: the Nuremberg Code and human experimentation ethics in Britain, 1946-73Jenny Hazelgrove
School of Nursing, University of Nottingham, UK
Soc Hist Med 15:109-35. 2002..In a similar move, their predecessors had helped to negotiate the Nuremberg Code in anticipation of public criticism of experimentation arising from the Nuremberg Medical Trial...
Informed consent for pediatric research: is it really possible?Eric Kodish
J Pediatr 142:89-90. 2003
The case of Chester M. Southam: research ethics and the limits of professional responsibilityBeth Aviva Preminger
Cornell University Joan and Sanford I. Weill Medical College, USA
Pharos Alpha Omega Alpha Honor Med Soc 65:4-9. 2002
Educating researchers: ethics and the protection of human research participantsJulie Rothstein Rosenbaum
Yale University School of Medicine, New Haven, CT, USA
Crit Care Med 31:S161-6. 2003....
Ethics review procedures for research in developing countries: a basic presumption of guiltRobert H Gilman
Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Md. 21205, USA
CMAJ 171:248-9. 2004
Module one: introduction to research ethicsUdo Schuklenk
University of the Witwatersrand Division of Bioethics WITS 2050, South Africa
Dev World Bioeth 5:1-13. 2005....
The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nationsFinnuala Kelleher
Columbia Journal of Law and Social Problems, Columbia University, USA
Columbia J Law Soc Probl 38:67-106. 2004....
Parallel experience: how art and art theory can inform ethics in human researchL Schwartz
McMaster University, Department of Clinical Epidemiology and Biostatistics, HSC 3V43, 1200 Main Street West, Hamilton, Ontario, Canada, L8N 3Z5
Med Humanit 29:59-64. 2003..The application of art theory, which has already considered these problems, helps question and explore the ways in which the subject turned object of artistic or scientific interpretation can maintain some control and dignity...
Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigatorsKevin P Weinfurt
Duke University School of Medicine, USA
J Law Med Ethics 34:581-91, 481. 2006....
Bioethical malpractice: risk and responsibilities in human researchBarbara A Noah
Health Law and Policy, University of Florida Levin College of Law, P.O. Box 117629, Gainesville, FL 32611-7629, USA
J Health Care Law Policy 7:175-241. 2004
Researcher liability for negligence in human subject research: informed consent and researcher malpractice actionsRoger L Jansson
Wash Law Rev 78:229-63. 2003..In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense...
Protection of health research participants in the United States: a review of two casesAlison Douglass
59 Sefton St, Wadestown, Wellington, New Zealand
N Z Bioeth J 5:6-12. 2004..incompetent or intentional failure to adhere by ethical guidelines. There is considerable headway to be made in the United States, as in other countries, in the fostering and maintenance of robust systems of human research oversight...
Conducting ethical research in pediatrics: a brief historical overview and review of pediatric regulationsDouglas S Diekema
University of Washington, Treuman Katz Center for Pediatric Bioethics, Children s Hospital and Regional Medical Center, Seattle, Washington 98101, USA
J Pediatr 149:S3-11. 2006..Good research is ethical research, and that requires investigators who take seriously the importance of participant welfare, meaningful informed consent, and respect for research participants...
The limitations of "vulnerability" as a protection for human research participantsCarol Levine
United Hospital Fund
Am J Bioeth 4:44-9. 2004..Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges...
Ethical considerations in the recruitment of research subjects from hospitalized, cardiovascular patient populationsNalini Jairath
School of Nursing, The Catholic University of America, Washington, DC 20064, USA
J Cardiovasc Nurs 20:56-61. 2005..This content is illustrated using the authors' experiences recruiting hospitalized coronary artery bypass graft surgical patients for a research study...
Does research ethics rest on a mistake?Franklin G Miller
Department of Clinical Bioethics, National Institutes of Health, USA
Am J Bioeth 5:34-6; author reply W15-8. 2005
Regulatory and ethical principles in research involving children and individuals with developmental disabilitiesEric G Yan
Division of General Pediatrics, Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA
Ethics Behav 14:31-49. 2004..This article discusses many of the regulatory principles to ensure better research participation of children and individuals with DD: human rights, validity, distributive justice, beneficence/nonmaleficence, and autonomy...
Conflicts of interest in medical research: how much conflict should exceed legal boundaries?Kaley Klanica
Boston University School of Public Health, USA
J Biolaw Bus 8:37-45. 2005..Lastly, part four concludes by recommending a system of seven balanced reform measures that protect research subjects and the scientific integrity of medical research while encouraging scientific progress...
A quartet of criticismsHarold Y Vanderpool
University of Texas Medical Branch, USA
Am J Bioeth 5:16-9. 2005
The welcome reassessment of research ethics: is "undue inducement" suspect?Howard Brody
Michigan State University, USA
Am J Bioeth 5:15-6. 2005
Undue inducement: nonsense on stilts?Ezekiel J Emanuel
National Institutes of Health, USA
Am J Bioeth 5:9-13; discussion W8-11, W17. 2005
The current situation regarding the establishment of national ethical guidelines for biomedical research in Thailand and its neighboring countriesSomei Kojima
Asian Center of International Parasite Control, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
Southeast Asian J Trop Med Public Health 36:728-32. 2005..This indicates that further efforts should be made to establish research guidelines and/or principles dealing with the human genome...
Ethical considerations in phenomenological researchWendy Walker
School of Health Sciences, University of Birmingham, UK
Nurse Res 14:36-45. 2007..Wendy Walker examines some important ethical issues that researchers need to consider before and during phenomenological research. She argues that failure to address such issues means putting at risk the rights of research participants...
Beginning anew: same principles, different direction for research ethicsMary Simmerling
University of Chicago, USA
Am J Bioeth 5:44-6; author reply W15-8. 2005
Research versus innovation: real differencesHaavi Morreim
University of Tennessee Health Science Center, USA
Am J Bioeth 5:42-3; author reply W15-8. 2005
Does research ethics rest on a mistake? The common good, reasonable risk and social justiceAlex John London
Carnegie Mellon University
Am J Bioeth 5:37-9; author reply W15-8. 2005
How not to rethink research ethicsTom L Beauchamp
Georgetown University, USA
Am J Bioeth 5:31-3; author reply W15-8. 2005
Some questionable premises about research ethicsRuth Macklin
Albert Einstein College of Medicine, USA
Am J Bioeth 5:29-31; author reply W15-8. 2005
Reflections on 'Rethinking research ethics'Robert J Levine
Am J Bioeth 5:1-3; author reply W15-8. 2005
Response to Athula Sumathipala and Sisira Siribaddana, "Revisiting 'freely given informed consent' in relation to the developing world: the role of an Ombudsman" (AJOB 4:3)Bob Simpson
Am J Bioeth 5:W24-6. 2005
Excluding particular information from consent formsNeal Dickert
Department of Health Policy and Management, Phoebe R Berman Bioethics Institute, John Hopkins University Bloomberg School of Public Health, Hampton House 348, 624 N Broadway, Baltimore, MD 21205, USA
Account Res 12:33-45. 2005..Further, we argue that the regulations ought to be amended to reflect this obligation...
Rethinking research ethicsRosamond Rhodes
Mount Sinai School of Medicine
Am J Bioeth 5:7-28. 2005..These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research...
Research ethics in Internet-enabled research: human subjects issues and methodological myopiaJoseph B Walther
Department of Communication, Cornell University, 336 Kennedy Hall, Ithaca, NY 14853-4203, USA
Ethics Inf Technol 4:205-16. 2002....
The history and moral foundations of human-subject researchJeffry Blustein
Division of Bioethics, Montefiore Medical Center and the Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York 10461, USA
Am J Phys Med Rehabil 86:82-5. 2007
Part I: what is the requirement for data sharing?Virginia A de Wolf
IRB 27:12-6. 2005
Undue inducement: the only objection to payment?Ari VanderWalde
UCLA, USA
Am J Bioeth 5:25-7. 2005
Can we ensure that all research subjects give valid consent?David Wendler
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
Arch Intern Med 164:2201-4. 2004..Future research should focus on developing a postdecision questionnaire that can be adapted to individual studies and used to assess the voluntariness and understanding of all research subjects...
Clinical research 2: legal and ethical issues in researchR Endacott
La Trobe University, PO Box 199, Bendigo, Vic. 3552, Australia
Intensive Crit Care Nurs 20:313-5. 2004
Human research protections: time for regulatory reform?Karen J Maschke
Hastings Cent Rep 38:19-22. 2008
Quality-improvement research and informed consentFranklin G Miller
Department of Bioethics, National Institutes of Health, Bethesda, MD, USA
N Engl J Med 358:765-7. 2008
Bioethics, vulnerability, and protectionRuth Macklin
Department of Epidemiology and Population Health, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461, USA
Bioethics 17:472-86. 2003..In addition, human rights principles are increasingly being used to monitor the actions (or inaction) of governments regarding women's reproductive rights and vulnerability with respect to HIV/AIDS, and to take remedial actions...
Research firm changes subject notification procedure after complaint by potential subjectDennis M Maloney
The Deem Corporation, P.O. Box 44069, Omaha, NE 68144, USA
Hum Res Rep 17:6-7. 2002
Conducting empirical research on informed consent: challenges and questionsGreg A Sachs
Department of Medicine, University of Chicago, USA
IRB . 2003
Institutional review boards and the privacy of human research subjectsDennis M Maloney
The Deem Corporation, P.O. Box 44069, Omaha, NE 68144, USA
Hum Res Rep 17:1-2. 2002
Intrinsic conflicts of interest in clinical research: a need for disclosureSharmon Sollitto
Case Western University School of Law, Cleveland, OH, USA
Kennedy Inst Ethics J 13:83-91. 2003..These conflicts should be disclosed to research subjects and managed as assiduously as are financial conflicts of interest...
Clinical trials face heightened scrutiny as science and commerce appear to mergeAlvin J Lorman
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, USA
J Biolaw Bus 4:23-32. 2001..The risk of increased government involvement includes criminal prosecution of physicians for failing to follow the rules, as an innovative case in California demonstrates...
Informing study participants of research results: an ethical imperativeConrad V Fernandez
Division of Pediatric Hematology/Oncology, Department of Pediatrics, IWK Health Centre and Dalhousie University, Halifax, Nova Scotia, Canada
IRB 25:12-9. 2003
Children in clinical research: a conflict of moral valuesVera Hassner Sharav
The Alliance for Human Research Protection
Am J Bioeth 3:W-IF 2. 2003....
Harming through protection?Mary Ann Baily
Hastings Center, Garrison, NY, USA
N Engl J Med 358:768-9. 2008
Ten questions institutional review boards should ask when reviewing international clinical research protocolsDaniel W Fitzgerald
IRB 25:14-8. 2003
Human subjects. Crossing a frontier: research on the deadJennifer Couzin
Science 299:29-30. 2003
University failed to have adequate IRB policies and procedures in placeDennis M Maloney
The Deem Corporation, P.O. Box 44069, Omaha, NE 68144, USA
Hum Res Rep 17:6-7. 2002
Human subjects protection and cultural anthropologyStuart Plattner
National Science Foundation, USA
Anthropol Q 76:287-97. 2003
Paying research subjects: an analysis of current policiesNeal Dickert
W.G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland 20892-1156, USA
Ann Intern Med 136:368-73. 2002..CONCLUSIONS: Most organizations pay some research subjects, but few have written policies on payment. Because investigators and institutional review boards make payment decisions with little specific guidance, standards vary...
Research Grants
- Lyophilization of Plasmodium falciparum sporozoite vaccineStephen Hoffman; Fiscal Year: 2007..Additionally, a dried vaccine may accelerate a concerted world-wide effort to eradicate this devastating disease. ..
- PARP inhibitor therapy for septic shockAndrew Salzman; Fiscal Year: 2004..Based on pre-clinical porcine shock models and clinical safety studies, we expect INO-1001 to be a safe, well-tolerated and effective therapeutic in patients with septic shock. ..
- PATHOGENESIS OF HAEMOPHILUS DUCREYI INFECTIONSStanley M Spinola; Fiscal Year: 2010..Chancroid can be treated with only three types of antibiotics. The genes controlled by the stress response systems may prove to be targets of vaccines or alternative treatments for H. ducreyi infection. ..
- MODEL OF HYPERCORTISOLISM FOR MAJOR DEPRESSIONSAlan Schatzberg; Fiscal Year: 1999....
- Resistant E.coli in Humans and PoultryJames Johnson; Fiscal Year: 2005..Does the research address a current and compelling problem of antimicrobial resistance that is of high public health importance and for which research is needed? [yes]. ..
- PHOSPHORYLATION OF CILIARY TARGET PROTEINSMATTHIAS A SALATHE; Fiscal Year: 2010..This proposal thus may identify new therapeutic targets that could help to decrease the burden from airway disease exacerbations on individuals and on society. ..
- Harmful effects of transfusion of older stored red cells: iron and inflammationSteven Spitalnik; Fiscal Year: 2009....
- MARKERS OF HUMAN INFECTION WITH BOVINE LEUKEMIA VIRUSGERTRUDE BUEHRING; Fiscal Year: 2007....
- IMMUNOCHEMISTRY OF GONOCOCCAL LIPOPOLYSACCHARIDEJOHN GRIFFISS; Fiscal Year: 2003..Gonococci shed during gonorrhoea make larger LOS. The higher Mr LOS made by MS11mkC - a strain used in human experimentation -have polylactosamine structures...
- Dietary HDAC Inhibitors in Colon Cancer PreventionRoderick H Dashwood; Fiscal Year: 2010....
- Potency of cryopreserved, irradiated sporozoite vaccineStephen Hoffman; Fiscal Year: 2005..The project will also provide a method for cryopreserving unirradiated sporozoites that could be used to challenge volunteers by injection with P. falciparum in vaccine studies worldwide. ..
- Imaging Cytolytic T Cells in Cancer Patients Using PET Reporter Genes/Reporter PrSanjiv S Gambhir; Fiscal Year: 2010..Here, we propose non-invasive imaging of therapeutic immune cells that will be infused into patients with glioma brain tumors and have been shown to kill glioma brain tumor cells. ..
- Genetically Attenuated Malaria Sporozote VaccineStephen Hoffman; Fiscal Year: 2007..Success in this project has the potential to lead to development of a safe, effective, attenuated malaria vaccine. ..
- Gene-engineered dendritic cell therapy for diabeticsMassimo Trucco; Fiscal Year: 2006..The ultimate result could include less intensive or even a complete cessation of insulin replacement therapy in newly-diagnosed diabetics as well as, perhaps, a means of preventing diabetes. ..
- Inhalation Dosimetry/Exposure Index of Fiber AerosolYung Sung Cheng; Fiscal Year: 2006..Sampling devices based on this size-selection definition can be developed in the future for improved assessment of worker exposure. ..
- SEVERE PERIODONTITIS AS A RHEOLOGIC MODIFIERSTEVEN ENGEBRETSON; Fiscal Year: 2003..Dr. Engebretson will receive training in research methodology and molecular biology in order to explore the mechanisms of periodontal medicine through the conduct of human clinical studies as a career goal. ..
- Translation Research in Plasmodium vivaxSocrates Herrera; Fiscal Year: 2005..abstract_text> ..
- An ACE Inhibitor as a Treatment for Methamphetamine DependenceTHOMAS FREDERICK NEWTON; Fiscal Year: 2010..A separate human laboratory study will examine the dose-dependent effects of perindopril on MA- induced craving, though these participants will not take part in the clinical trial. ..
- An ACE Inhibitor as a Treatment for Methamphetamine DependenceThomas Newton; Fiscal Year: 2009..A separate human laboratory study will examine the dose-dependent effects of perindopril on MA- induced craving, though these participants will not take part in the clinical trial. ..
- Immune function and the progression to type 1 diabetesMark Atkinson; Fiscal Year: 2007....
- Role of Leptin in the Neuroendocrine Response to FastingChristos Mantzoros; Fiscal Year: 2004....
- PH CONTROL OF PROTEIN SYNTHESISPeter Garlick; Fiscal Year: 2003..abstract_text> ..
- Dietary HDAC Inhibitors in Colon Cancer PreventionRoderick Dashwood; Fiscal Year: 2009....
- PATHOGENESIS OF HAEMOPHILUS DUCREYI INFECTIONSSTANLEY SPINOLA; Fiscal Year: 1999....
